Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.25g, For single ...
FDA Device Recall #Z-2145-2019 — Class II — April 12, 2019
Recall Summary
| Recall Number | Z-2145-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 12, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Geistlich Pharma North America, Inc. |
| Location | Princeton, NJ |
| Product Type | Devices |
| Quantity | 244,268 total |
Product Description
Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.25g, For single use only, Part Number 20115 - Product Usage: Augmentation or reconstructive treatment of the alveolar ridge; Filling of infrabony periodontal defects; Filling of defects after root resection, apicoectomy and cystectomy; Filling of extraction sockets to enhance preservation of the alveolar ridge; Elevation of the maxillary sinus floor, etc.
Reason for Recall
When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen.
Distribution Pattern
US Nationwide distribution.
Lot / Code Information
Lots: 81600759, 81700193, 81700810, 81701004, 81800288, 81800862, 81900056.
Other Recalls from Geistlich Pharma North America, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0492-2021 | Class II | Geistlich Bio-Oss Pen 1-2mm 0.5g - Product Usag... | Oct 19, 2020 |
| Z-0491-2021 | Class II | Geistlich Bio-Oss Pen 0.25-1mm 0.5g - Product U... | Oct 19, 2020 |
| Z-0490-2021 | Class II | Geistlich Bio-Oss Pen 0.25-1mm 0.25g - Product ... | Oct 19, 2020 |
| Z-2147-2019 | Class II | Geistlich Bio-Oss Pen, Sterile cancellous granu... | Apr 12, 2019 |
| Z-2146-2019 | Class II | Geistlich Bio-Oss Pen, Sterile cancellous granu... | Apr 12, 2019 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.